Medical Device Reportingfor Manufacturers

DEPARTMENT OF HEALTH AND HUMAN SERVICESPublic Health Service

Food and Drug Administration

Medical Device Reportingfor Manufacturers

Prepared byDivision of Small Manufacturers Assistance

Office of Health and Industry Programs

Project Officers: Bryan Benesch, Ron Parr and Timothy Stockdale

March 1997

DEPARTMENT OF HEALTH AND HUMAN SERVICESPublic Health Service

Food and Drug AdministrationCenter for Devices and Radiological Health

Rockville, Maryland 20850

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FOREWORD

The Center for Devices and Radiological Health (CDRH) of the Food and DrugAdministration (FDA) develops and implements national programs and regulations to protect thepublic health in the fields of medical devices and radiological health. These programs are intendedto insure the safety, effectiveness, and proper labeling of medical and radiation-emitting devices.

CDRH publishes the results of its work in scientific journals and in its own technicaldocuments. Through these documents, CDRH also provides assistance to industry and to themedical and health professional communities in complying with the laws and regulations mandatedby Congress. The reports are sold by the Government Printing Office, the National TechnicalInformation Service, and private publishers. Many reports are also available on the World WideWeb.

We welcome your comments and requests for further information.

D. Bruce Burlington, M.D.DirectorCenter for Devices and Radiological Health

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PREFACE

The Safe Medical Devices Act of 1990 (SMDA) imposed significant new reportingrequirements on the medical device industry and users of medical devices. This guidancedocument is based on the final Medical Device Reporting (MDR) regulation published December11, 1995, in the Federal Register. The final MDR regulation addresses changes mandated by theSMDA and the Medical Device Amendments of 1992.

Much of the information in this document is general in nature and may not apply to a specificsituation. Questions should be sent by FAX to 301-827-0038 or mailed to the:

Food and Drug AdministrationCenter for Devices and Radiological HealthDivision of Surveillance Systems (HFZ-530)Medical Device Reporting (MDR) Inquiries1350 Piccard DriveRockville, MD 20850

Please include your name, return address, phone number, and (if applicable) FAX number withyour questions.

This guidance for manufacturers is one of three documents written for a particular audience: user facilities, manufacturers, and distributors. All are available through the Internet/World WideWeb at: http://www.fda.gov/cdrh and from the National Technical Information Service,Springfield, Virginia 22161, telephone number 703-487-4650.

John StigiDirectorDivision of Small Manufacturers Assistance

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ABSTRACT

Benesch, B., Parr, R., and Stockdale, T., Project Officers. Department of Health and HumanServices, Center for Devices and Radiological Health, Medical Device Reporting forManufacturers.

This guidance document describes the new Medical Device Reporting requirements formanufacturers. It is intended for both domestic and foreign medical device manufacturers, and isbased on the Medical Device Reporting (MDR) requirement published in the final rule datedDecember 11, 1995. The MDR regulation provides a mechanism for FDA to identify andmonitor significant adverse events involving medical devices, so that problems may be detectedand corrected in a timely manner.

The purpose of this document is to provide domestic and foreign manufacturers with:

• a thorough description of the current MDR regulation,

• a clear understanding of their reporting responsibilities,

• guidance to help in the completion of the MDR forms,

• an overview of required written MDR procedures, records and files, and

• information on sources for forms, instructions, and other MDR information.

Although this guidance does not create or confer any rights, for or on any person,and does not operate to bind FDA or the public, it does represent the agency’s currentthinking on the Medical Device Reporting regulation.

Where this document reiterates a requirement imposed by statute or regulation, theforce and effect as law of the requirement is not changed in any way by virtue of itsinclusion in this document.

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ACKNOWLEDGMENTS

A wide range of professionals within the Center for Devices and Radiological Health (CDRH)contributed both time and expertise in the effort to prepare this document for publication. CDRHacknowledges the following individuals for their efforts:

Jessie Auerbach, Alfie Barcome, Sue Ellen Bounds, Kay Cook, Susan Gardner, Nancy Lowe,Chester Reynolds, Suzanne Rich, Earl Wayne Robinson, David Shindell, Patricia Spitzig,Marquita Steadman, John Stigi, Crystal Thompson and Al Thomas.

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CONTENTS

Foreword ................................................................................................................................... iiPreface...................................................................................................................................... iiiAbstract ..................................................................................................................................... ivAcknowledgments....................................................................................................................... v

1. INTRODUCTION

Changes affecting the Federal Register Final Rule Published on December 11, 1995.............2Table 1 - Summary of Reporting Requirements for Manufacturers .......................................6Table 2 - Summary of Reporting Requirements for User Facilities and Distributors..............7

2. MANUFACTURER REPORTING REQUIREMENTS

Who Must Report...............................................................................................................8When and What to Report ..................................................................................................8When Not to Submit a Report .......................................................................................... 10Types of Reports .............................................................................................................. 11FDA Requests for Additional Information......................................................................... 17Reporting for Foreign Manufacturers................................................................................ 17Reporting for User Facilities and Distributors ................................................................... 19Where to Submit Reports ................................................................................................ 19Where to Report a Public Health Emergency .................................................................... 20English Reporting Requirements....................................................................................... 20Electronic Reporting......................................................................................................... 20Exemptions, Variances, and Alternative Reporting Requirements...................................... 21How to Report ................................................................................................................. 23Reporting Codes (Coding Manual) ................................................................................... 24

3. WRITTEN PROCEDURES, RECORD KEEPING ANDPUBLIC DISCLOSURE

Written Procedures .......................................................................................................... 25MDR Event Files.............................................................................................................. 26Public Availability of Reports............................................................................................ 27Disclaimers....................................................................................................................... 28

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4. ENFORCEMENT

FDA-initiated or Voluntary Recalls................................................................................... 29Civil Money Penalties ....................................................................................................... 29Warning Letters................................................................................................................ 29Seizure ............................................................................................................................. 29Citation ............................................................................................................................ 30Injunction ......................................................................................................................... 30Prosecution ...................................................................................................................... 30

5. TERMS AND DEFINITIONS

Becomes Aware ............................................................................................................... 31Caused or Contributed...................................................................................................... 31Complaint......................................................................................................................... 31Device Family................................................................................................................... 32Disclaimers....................................................................................................................... 32Distributor........................................................................................................................ 33Expected Life ................................................................................................................... 33Information Reasonably Known........................................................................................ 33Malfunction ...................................................................................................................... 33Manufacturer.................................................................................................................... 34Manufacturer Report Number (MedWatch Form 3500A).................................................. 34Medical Personnel ............................................................................................................ 35MDR Reportable Events................................................................................................... 35Permanent Impairment...................................................................................................... 35Person Qualified to Make a Medical Judgement................................................................ 35Reasonably Suggests ........................................................................................................ 35Remedial Action ............................................................................................................... 36Serious Injury/Serious Illness............................................................................................ 36Shelf Life.......................................................................................................................... 36User Error ........................................................................................................................ 36User Facility ..................................................................................................................... 36Work Day......................................................................................................................... 36

APPENDIX

A. Sources of Available MDR Related Documents ............................................................. 37B. Sources of Manufacturer Assistance for Complying with the MDR Regulation............... 41

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1 INTRODUCTION

On July 31, 1996, the new Medical Device Reporting (MDR) regulation became effective foruser facilities and device manufacturers. This document describes the current provisions fordevice manufacturers.

The MDR regulation provides a mechanism for the Food and Drug Administration (FDA) andmanufacturers to identify and monitor significant adverse events involving medical devices. Thegoals are to detect and correct problems in a timely manner. Although the requirements of theregulation can be enforced through legal sanctions authorized by the Federal Food, Drug andCosmetic (FD&C) Act, FDA relies on the goodwill and cooperation of all affected groups toaccomplish the objectives of the regulation.

The statutory authority for the MDR regulation is section 519 of the FD&C Act as amendedby the Safe Medical Devices Act (SMDA) of 1990. The SMDA requires user facilities to report:

• device-related deaths to the FDA and the device manufacturer;

• device-related serious injuries and serious illnesses to the manufacturer, or to FDA ifthe manufacturer is not known; and

• submit to FDA on a semiannual basis a summary of all reports submitted during thatperiod.

The SMDA requires FDA to issue regulations requiring distributors to report device-relateddeaths, serious injuries and reportable malfunctions. On September 1, 1993, FDA published afinal MDR reporting regulation for distributors, including provisions for importers that becameeffective on October 1, 1993. In addition, the SMDA requires distributors and manufacturers tocertify to FDA the number of MDR reports filed or that no reports have been filed.

The user facility reporting section of SMDA became effective on November 28, 1991. Devicemanufacturers should familiarize themselves with the user facility requirements and read theguidance document entitled, “Medical Device Reporting for User Facilities.” (Refer to AppendixA).

Since 1984, domestic manufacturers have been subject to the MDR regulation if they wererequired to register their establishment with the FDA. The new MDR regulation eliminates thislink with registration. All manufacturers of finished medical devices and components which areready for use, including foreign manufacturers, are now subject to the requirements of the MDRregulation, despite registration status.

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To carry out the reporting provisions of SMDA, FDA published a tentative final rule in theFederal Register (FR) on November 26, 1991, proposing to implement reporting regulations forusers and distributors. In addition, the tentative final rule proposed to amend the existing 1984MDR reporting regulation for manufacturers. On June 16, 1992, President Bush signed into lawthe Medical Device Amendments of 1992 (Public Law 102-300; the Amendments of 1992),amending certain provisions (section 519 of the FD&C Act) that relate to the reporting of adverseevents. The primary impact of the 1992 Amendments on MDR reporting was to define certainterms and to establish a single reporting standard for user facilities, manufacturers anddistributors.

The final MDR regulation for user facilities and manufacturers, published in the FederalRegister on December 11, 1995, addresses the comments received by FDA on the November 29,1991, tentative final regulation and the changes mandated by the Amendments of 1992.

Significant changes for manufacturers from the 1984 MDR regulation include:

• different time frames for reporting• use of standardized reporting forms• removal of unanticipated temporary impairments• new definitions• addition of an FDA disclaimer• removal of the “per se” rule

• requirement for foreign manufacturers to have a U.S. Designated Agent (USDA) forreporting MDR events to FDA. (STAYED 7/23/96)

CHANGES AFFECTING THE FEDERAL REGISTER FINAL RULE PUBLISHED ON DECEMBER 11, 1995

FDA began to receive comments regarding the regulation, following publication of theDecember 11, 1995, final rule on Medical Device Reporting for manufacturers and user facilities. FDA staff subsequently met with representatives of the Health Industry ManufacturersAssociation (HIMA), and other industry representatives to discuss their concerns about the newregulation. Following these discussions, FDA decided to place all or portions of three specificparts of the regulation into abeyance. This means that FDA has revoked/stayed, or delayed theseparts from going into effect.

Therefore:

1) Foreign manufacturers are not required to have a USDA;

2) There is no requirement to submit distribution information dictated by sections803.55(b)(9) and (10) of the baseline reporting requirement. This means that

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manufacturers do not fill out data elements 15 and 16 only of the baseline report (FormFDA 3417);

3) A foreign manufacturer is fully subject to the medical devices reporting requirements. If aforeign manufacturer already has a USDA, they may forward medical device reportsthrough this agent until further notice. However, if a foreign manufacturer chooses toemploy a contact in the United States (U.S.) to forward reports to FDA, FDA views thisperson as if he or she is an employee of the foreign firm. FDA explains these decisions inthe Federal Register (FR) notices summarized below; and

4) FDA encourages foreign firms to register with FDA by completing a Form FDA 2891,“Initial Registration of Device Establishment.”

Below are summaries of each of the four notices.

FEDERAL REGISTER SUMMARIES

1st Notice, Federal Register, July 23, 1996: Stay of Effective Date; Revocation of Final Rule (Document available from the CDRH Facts on Demand, Document Number 1074; see AppendixA).

In this FR notice, the FDA changed the MDR requirements as follows:

• The effective date of the annual certification provision of the MDR regulation formanufacturers and distributors was stayed.

• Annual certification provisions for manufacturers were stayed to allow FDA to address

industry concerns. FDA reproposed this provision as described below. • The existing requirement for distributors to annually certify was revoked (§804.30). It

was also reproposed, so that manufacturers and distributors would be treated the sameregarding certification; and

• The U.S. designated agent requirements for foreign manufacturers were stayed (§803.58).

In addition, foreign manufacturers, as of July 31, 1996, have a responsibility to comply withall remaining medical device reporting requirements. The original medical device reportingregulation that became effective on December 14, 1984, defined a manufacturer required tosubmit MDR reports, as any person FDA required to register under Part 807. Since foreignmanufacturers are not required to register, the December 1984 regulation was not applied tothem. The new medical device reporting regulation, published December 11, 1995, no longerdefines a manufacturer as a person whom FDA requires to register under Part 807. Under section803.3(n), a manufacturer is defined as any person who manufactures, prepares, propagates,

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compounds, assembles, or processes a device by chemical, physical, biological, or otherprocedure(s). Accordingly, foreign manufacturers fit within the new definition of manufacturersthat FDA requires to submit MDR reports.

Therefore, as of July 31, 1996, all manufacturers, including foreign manufacturers, are subjectto all requirements of 21 CFR Part 803 (MDR Reporting) including, but not limited to:

• the requirements for written MDR procedures (§803.17),• MDR event files (§803.18),• individual adverse event reports (§803.50 and §803.52),• five-day MDR reports (§803.53),• MDR baseline reports (§803.55), and• MDR supplemental reports (§803.56).

In addition, the regulations that are now in effect, and will remain in effect during the stay,permit foreign manufacturers to:

• register their companies using Form FDA 2891, “Medical Device EstablishmentRegistration,” [§807.40(a)], and

• submit premarket notifications [510(k)s] (§807.81).

These regulations also require foreign manufacturers to list their devices on Form FDA 2892,medical “Device Listing,” [§807.40(b)]. (Refer to the “Reporting for Foreign Manufacturer”section for the correct version of §807.40.)

2nd Notice, Federal Register, July 23, 1996: Medical Device Reporting; Certification andU.S. Designated Agents (USDA); Proposed Rule. (Document available from the CDRH Factson Demand, Document Number 1075; see Appendix A.)

In this FR notice, FDA reproposed the annual certification requirements for manufacturersand distributors. The proposed annual certification changes:

• eliminate the current certification statement;

• substitute a new certification statement that states that the certifying official has;

- read the MDR regulation,- made certain that the manufacturer has established an MDR reporting system, and- determined that a certain number of reports, or no reports, have been submitted.

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• provide flexibility by allowing firms to identify the certifying agent for annual certification,rather than requiring the certifying agent to be the Chief Executive Officer or the Presidentof the company.

3rd Notice, Federal Register, July 31, 1996: Baseline Reports, Stay of Effective Date(Document available from the CDRH Facts on Demand, Document Number 1096; see AppendixA.)

In this FR notice, FDA placed into abeyance, or stayed, the effective date of the provision ofthe MDR regulation that relates to part of the baseline reporting requirement [21 CFR803.55(b)(9) and (10)]. Therefore, at this time, FDA will not require any manufacturer to submitdenominator data requested in Part II, Items 15 and 16 only on Form FDA 3417, “BaselineReport.” Instead, FDA will initiate a demonstration project to evaluate denominator data. At thecompletion of this project, FDA will either lift the stay, retain it, or repropose these specificrequirements.

4th Notice, Federal Register, March 20, 1997: Medical Device Reporting; AnnualCertification; Final Rule (Document available from the CDRH Facts on Demand, DocumentNumber 1090; see Appendix A).

In this FR notice, FDA amended its medical device manufacturer and distributor certificationregulations to allow manufacturers to designate more than one certifying official, each of whomwould sign a certification statement for his or her identified organizational component or site; andto amend the certification statement to minimize concerns relating to liability from unintentionalreporting errors and indicate that the certifying official is making the certification statements, tothe best of his/her knowledge and belief. This action was taken to help FDA carry out its publichealth protection responsibilities relating to medical devices. This action provides reportingentities with greater flexibility in the certification process while reducing the regulatory burden. This amendment is effective on May 19, 1997, and replaces the requirement that was stayed onJuly 23, 1996..

A summary of the reporting requirements for manufacturers is provided in Table 1. Reportingrequirements for user facilities and distributors are summarized in Table 2.

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TABLE 1 - Summary of Reporting Requirements for Manufacturers

REPORTER WHAT TO REPORT REPORTFORM #

TOWHOM

WHEN

Manufacturer 30 day reports of deaths,serious injuries andmalfunctions

Form FDA3500A

FDA Within 30 calendardays from becomingaware of an event

Manufacturer 5-day reports on events thatrequire remedial action toprevent an unreasonable riskof substantial harm to thepublic health and other typesof events designated by FDA

Form FDA3500A

FDA Within 5 work daysfrom becoming awareof an event

Manufacturer Baseline reports to identifyand provide basic data on eachdevice that is subject of anMDR report. At this time,FDA has stayed therequirement for denominatordata requested in Part II,Items 15 and 16 on Form3417.

Form FDA3417

FDA With 30 calendar, and5 work day reportswhen device or devicefamily is reported forthe first time. Interimand annual updatesare also required ifany baselineinformation changesafter initialsubmission.

Manufacturer Annual Certification Form FDA3381

FDA Coincide with firm’sannual registrationdates.

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TABLE 2. - Summary of Reporting Requirements for User Facilities andDistributors

REPORTER WHAT TOREPORT

REPORTFORM #

TO WHOM WHEN

User Facility Death Form FDA3500A

FDA & Manufacturer Within 10work days

User Facility Serious injury Form FDA3500A

Manufacturer. FDAonly if manufacturerunknown

Within 10work days

User Facility Semiannual reportsof death & seriousinjury

Form FDA 3419 FDA January 1 &July 1

Distributor

(includesimporters)

Death & seriousinjury

Form FDA3500A(optional)

FDA Within 10work days

Distributor

(includesimporters)

Death, serious injury& malfunction

Form FDA3500A(optional)

Manufacturer Within 10work days

Distributor

(includesimporters)

Annual Certification Form FDA 3381 FDA Annually

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2 MANUFACTURERREPORTING REQUIREMENTS

Manufacturers must report device-related deaths, serious injuries, and malfunctions to FDAwhenever they become aware of information that reasonably suggests that a reportable eventoccurred (one of their devices has or may have caused or contributed to the event).

WHO MUST REPORT [§803.3(n)]

All manufacturers of finished medical devices commercially distributed in the U. S., includingforeign manufacturers who export devices to the U.S., are required to comply with the MDRregulation.

A manufacturer [§803.3(n)] is any person who manufactures, prepares, propagates,compounds, assembles, or processes a device by chemical, physical, biological or otherprocedures. The term includes any person who:

• repackages or otherwise changes the container, wrapper or labeling of a device infurtherance of the distribution of the device from the original place of manufacture;

• initiates specifications for devices manufactured by a second party for subsequentdistribution by the person initiating the specifications; or

• manufactures components or accessories which are devices that are ready to be usedand are intended to be commercially distributed and intended to be used as is, or areprocessed by a licensed practitioner or other qualified person to meet the needs of aparticular patient; or

•

WHEN AND WHAT TO REPORT [§803.3(q)]

Manufacturers must report all MDR reportable events (see definition) to FDA on FormFDA 3500A. Each manufacturer shall review and evaluate all complaints (see definition) todetermine whether the complaint represents an event which is required to be reported to FDA. A separate Form 3500A is required for each device involved in a reportable event. Forexample, if a manufacturer receives a report from a user facility which indicates that more thanone of the manufacturer’s devices may have been involved in a reportable event, a separatereport for each device is required. A report is required when a manufacturer becomes aware(see definition) of information that reasonably suggests that one of their marketed devices has

is the US Designated Agent of a foreign manufacturer. STAYED 7/23/96

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or may have caused or contributed to a death, serious injury, or has malfunctioned and that thedevice or a similar device marketed by the manufacturer would be likely to cause or contributeto a death or serious injury if the malfunction were to recur.

Serious injury/(Serious illness) [§803.3(aa)(1)] is an injury or illness that:

• is life threatening, even if temporary in nature;

• results in permanent impairment of a body function or permanent damage to a bodystructure; or

• necessitates medical or surgical intervention to preclude permanent impairment of abody function or permanent damage to a body structure.

A malfunction [§803.3(m)] is a failure of the device to meet its performance specificationsor otherwise perform as intended. Performance specifications include all claims made in thelabeling for the device. A malfunction should be considered reportable if any one of thefollowing is true:

• the chance of a death or serious injury occurring as a result of a recurrence of themalfunction is not remote;

• the consequences of the malfunction affect the device in a catastrophic manner thatmay lead to a death or serious injury;

• it causes the device to fail to perform its essential function and compromises thedevice’s therapeutic, monitoring or diagnostic effectiveness which could cause orcontribute to a death or serious injury, or other significant adverse device experiences.The essential function of a device refers not only to the device’s labeled use, but forany use widely prescribed within the practice of medicine;

• it involves an implant malfunction that would be likely to cause or contribute to deathor serious injury, regardless of how the device is used;

• the device is considered life-supporting or life-sustaining, and thus essential tomaintaining human life; or

• the manufacturer takes or would be required to take action under section 518 or 519(f)of the FD&C Act as a result of the malfunction of the device or other similar devices.

Reporters do not need to assess the likelihood that a malfunction will recur. Theregulation presumes that the malfunction will recur. Furthermore, FDA believes that once amalfunction has caused or contributed to a death or serious injury, a presumption that themalfunction is likely to cause or contribute to a death or serious injury has been established.

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This presumption will continue until the malfunction has caused or contributed to no furtherdeaths or serious injuries for two years, or the manufacturer can show, through valid data, thatthe likelihood of another death or serious injury as a result of the malfunction is remote.

Malfunctions are not reportable if they are not likely to result in a death, serious injury orother significant adverse event experience.

A malfunction which is or can be corrected during routine service or device maintenancemust be reported if the recurrence of the malfunction is likely to cause or contribute to adeath or serious injury if it were to recur.

WHEN NOT TO SUBMIT A REPORT [§803.22]

FDA requires only one medical device report from the manufacturer if they become awareof information from multiple sources regarding the same patient and the same event. Also, forcontract manufacturers, FDA would expect only one report from either the specificationsdeveloper or the contract manufacturer for one reportable event. Nevertheless, there must bea written agreement which identifies which party is responsible for completing Form 3500A.

In addition, FDA does not require that a manufacturer submit an MDR report:

• when the manufacturer determines that the information that they received is erroneousand a death or serious injury did not occur; or

• when another manufacturer made the device.

Manufacturers should retain documentation of erroneous reports in their MDR files fortwo years from the date of the event or a period equivalent to the expected life of the device,whichever is longer.

Any reportable event information that is erroneously sent to manufacturer A, for a devicemade by manufacturer B, should be sent to the FDA (Refer to “Where to Submit Reports” inthis chapter) with a cover letter explaining that manufacturer A does not make the device inquestion.

Again, malfunctions are not reportable if they are not likely to result in a death, seriousinjury or other significant adverse event experience.

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TYPES OF REPORTS

There are five types of MDR reports that FDA requires the manufacturer to submit. Eachtype of report is to be submitted within the mandatory time frame by completing theappropriate form. MDR reports for manufacturers include a:

1) 30-day report,2) 5-day report,3) baseline report,4) supplemental report, and5) annual certification.

1) 30-Day Report [§803.50]

Manufacturers are required to submit an individual adverse event (MDR) report to FDA,on form FDA 3500A (mandatory MedWatch form), or electronic equivalent as approved byFDA, within 30 calendar days after becoming aware of a reportable death, serious injury, ormalfunction. FDA has developed instructions for completing the Form 3500A and a codingmanual for specific items on the form (Refer to Appendix A for obtaining copies.)

FDA believes that manufacturers have a direct responsibility to inform all employees toforward immediately adverse event information to the appropriate person appointed by thoseentities to submit MDR reports.

Accordingly, FDA generally considers that a manufacturer becomes aware of an adverseevent whenever any employee becomes aware of an adverse event. The 30-day time framebegins the day after receipt of the information that reasonably suggests that an MDRreportable event has occurred.

Manufacturers may receive complaint information via telephone, facsimile, writtencorrespondence, sales representative report, service representative report, scientific articlereview, internal analyses or direct FDA contact. The manufacturer should make certain thatmarket, sales, engineering, manufacturing, regulatory, installation and service personnel aretrained to properly identify and report complaints.

User facilities and distributors will also submit information to the manufacturer on Form3500A. However, the manufacturer will find that user facilities and distributors may needsome guidance regarding when to use Form 3500A. For example, if a user facility calls in adeath or a serious injury report, it behooves the manufacturer to remind the user facility tocomplete a Form 3500A immediately and report a death to FDA. Otherwise, it will be theresponsibility of the manufacturer to complete the entire Form 3500A and submit it within 30days. FDA encourages manufacturers to help user facilities in gaining an understanding ofuser facility obligations.

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Manufacturers may also receive adverse event information from the submission of avoluntary MedWatch report form (Form 3500). When the FDA MedWatch Program Officereceives a voluntary Form 3500 involving a medical device, it is forwarded to the Center forDevices and Radiological Health (CDRH) for follow-up. The Office of Surveillance andBiometrics (OSB) within CDRH will forward a copy of the report to the manufacturer forevaluation. If the event is reportable, the reporting time frame for reporting begins when theform is received. The manufacturer has now “become aware” of the event. If a firm decidesthat the event is reportable, then it must obtain all of the information required on a mandatoryForm 3500A and then submit the completed form to FDA.

Sometimes the initial reporter may request confidentiality, preventing the manufacturerfrom investigating the complaint. In these cases, the manufacturer must evaluate thereportability of the complaint based on the information they can obtain, any informationprovided in Form 3500, and their knowledge of the product. The manufacturer must base theMDR reportability decision on this information.

2) 5-day report [§803.53]

Upon receiving information about an MDR reportable event, a manufacturer must submit a“5-day report” to FDA on form FDA 3500A or electronic equivalent as approved by FDA,within five work days after: (1) becoming aware that a reportable event necessitates remedialaction to prevent an unreasonable risk of substantial harm to public health; or (2) becomingaware of an MDR reportable event from which FDA has made a written request for thesubmission of a 5-day report involving a particular type of medical device or type of event.

Unlike the 30-day report, the 5-day time frame for remedial actions begins the day afterany employee, who is a person with management or supervisory responsibilities over personswith regulatory, scientific, or technical responsibilities, or a person whose duties relate to thecollection and reporting of adverse events, “becomes aware” that a reportable MDR event hasoccurred. FDA does not believe that certain employees, such as nontechnical staff, canprobably recognize that an adverse event or events may require remedial action to prevent asubstantial risk to the public. The 5-day time frame for reports requested by FDA begins whenany employee of the manufacturer becomes aware that a reportable event has occurred.

If the manufacturer must submit a 5-day report, the manufacturer should provide anyadditional information that is not available within the five days in a separate supplementalreport on Form 3500A.

Remedial action [§803.3(y)] is any action, other than routine maintenance or servicing ofa device, necessary to prevent recurrence of a reportable event. Not all remedial actions needto be submitted as 5-day reports. Only remedial actions that are necessary to prevent anunreasonable risk of substantial harm to the public health must be submitted. If themanufacturer takes a remedial action, but it is NOT to prevent an unreasonable risk ofsubstantial harm to the public health, no 5-day report is required. However, a 30-day report

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may be required. The discovery that a remedial action is necessary may be a direct result ofone or more MDR reportable events occurring, or may be discovered through the performanceof internal analyses using appropriate statistical or other acceptable methodologies. Actiontaken to fix a single device involved in an MDR reportable event is not remedial action.

FDA has published a Remedial Action Exemption Policy that establishes the conditionsunder which MDR reportable events, addressed by a remedial action, would no longer berequired to be reported under the MDR regulation. The Remedial Action Exemption (RAE)policy document, dated July 30, 1996, replaces the previous RAE policy, dated June 12, 1995. The new document, pursuant to the Medical Device Reporting (MDR) regulation, 21 CFR803.19, establishes the conditions under which MDR reportable adverse events would nolonger be required for deaths, serious injuries and malfunctions involving a product undergoingremedial action. (Refer to Appendix A.) This new policy will not affect those RAEs whichwere submitted before the July 31, 1996, effective date of the final rule. Exemptionsauthorized under the previous June 12, 1995, RAE policies are hereby reinstated and themanufacturer will not have to submit renewal notifications.

If the manufacturer becomes aware of an MDR reportable event for which FDA has madea written request for the submission of a 5-day report, the manufacturer must submit, withoutfurther requests, a 5-day report for each subsequent event of the same nature that involvessimilar devices for the time period specified in the written request. The FDA identificationrequest may be a result of its review of 30-day reports, inspection reports, user facility reports,or any other information.

FDA will generally relate 5-day report requests to severe, unusual, or unexpected events. The following is one possible scenario. There were a few unexplained pediatric deathsassociated with the use of a particular medical device. FDA met with the manufacturer and themanufacturer could detect no reason for the deaths. At this point, FDA may decide to requesta 5-day report concerning any other unexplained pediatric deaths for a specified period, forexample, six months. This will allow FDA to investigate in a timely manner whether thesedeaths were an anomaly or whether the device caused or contributed to the deaths.

Manufacturers required to complete 5-day reports for events requiring remedial actionshould send them to the post office box address for submission of MDR reports, but may call(301) 827-7537 to request instructions if they wish to send their reports via a facsimile.

3) Baseline report [§830.55]

Manufacturers must submit a baseline report (accompanying the corresponding Form3500A) when an event involving the device model or device family is reported for the firsttime. The manufacturer submits a baseline report to FDA using Form 3417, which providesbasic device identification information.

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As mentioned earlier, FDA published a July 31, 1996 Federal Register notice staying therequirements for distribution data (items 15 and 16) on the Medical Device BaselineReport until further notice.

The report can be submitted by model type (one baseline report for each model) or bydevice family (one baseline report for all models in that family). The instructions forcompleting the baseline report are contained in “Instructions for Completing the MedicalDevice Baseline Report, “FDA form 3417.” (Refer to Appendix A.)

A device family [§803.3(e)] is a group of one or more devices manufactured by or for thesame manufacturer and having the same:

• basic design and performance characteristics related to device safety and effectiveness;• intended use and function; and• device classification and product code.

FDA has classified approximately 1700 generic categories of devices. Each genericcategory is represented by a classification regulation in 21 CFR 800-1299. FDA has furtherdefined classification regulation through a product code nomenclature system. Thisinformation is available from the Product Code Classification Database on the World WideWeb. (Refer to Appendix A.)

Devices that differ only in minor features, unrelated to safety or effectiveness, can beconsidered in the same device family. Factors such as a brand name and common name, or thefact that the devices were introduced into commercial distribution under the same 510(k) orthe same premarket approval application (PMA), may be considered in determining thegrouping of products into device families.

If the manufacturer chooses the option of submitting a baseline report by device family,they must attach a list of all models in the family to the baseline report. To help manufacturersin submitting baseline reports by device family, FDA has developed a suggested matrix thatmay be used to list models included in a family. (Refer to the Instructions for Completing Form3417 in Appendix A.)

The basic device identification information, requested on Form 3417, includes: brandname, device family designation, model number, catalog number, and any other deviceidentification number. This information helps insure clear, unambiguous device identification. The information will enable FDA staff to identify the product reported, which is critical inevaluating the extent of the problem.

The baseline form also includes information on the shelf life and expected life of a device. There is no intent, by FDA, to require that all devices have a shelf life or expected life. If thereis no shelf life, manufacturers should check “N/A” in the block 11a of Form 3417. If theconcept of expected life is not applicable to the device, manufacturers should check “N/A” in

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block 11b. If no expected life has been established, then FDA considers the product to haveeither an indefinite life, or no established expected life. The absence of an expected life willaffect how long a manufacturer maintains required MDR event files for the device. (Refer to“MDR Event Files” in Chapter 3.)

Baseline reports on systems with multiple components. If a medical device consists ofseveral different stand alone medical device components, and one component is involved in areportable event, FDA may require a baseline report. If the component is a finished device,bearing its own unique device identifier, then a baseline report is submitted for the componentif the suspect device was the component. If the system has a device identifier and identifyingthe unique component is not possible, then file a baseline report on the entire system. Thispolicy does not apply to kits of assembled devices.

Baseline reports linked to 5-day reports. If a device, which is the subject of a 5-dayreport, is being reported for the first time, FDA requires a Form 3417 baseline report. Themanufacturer should submit as much information as can be obtained on the baseline report thatwill accompany the 5-day report. If not all the information can be obtained, the manufacturershould explain, in a cover letter, that they cannot obtain all information within the requiredreporting time frame, and provide an estimated date for submission of the remaininginformation. At a minimum, the initial baseline report should provide the device identificationinformation, that is, brand, model number, catalog number, product code, and device family.

Annual baseline update [§803.55(b)].

The annual update report shall be submitted at the same time that the firm’s annualregistration is required per Part 807.21. Annual baseline updates should cover the time periodfrom the initial baseline report or last annual update, whichever is later, to the present annualregistration filing. If the annual registration is due less than six months after the initial baselinereport is submitted, then the annual baseline update report would not be required until the nextannual registration is due. Manufacturers are required to submit annual baseline updatereports, using Form 3417, to notify FDA of any changes in original baseline report informationoccurring during the twelve-month period preceding their annual registration.

Changes requiring an annual baseline update include:

• the addition of models to a device family,• changes in information in blocks 1-14.

An annual update to a baseline report does not have to be submitted if, during the previoustwelve-month period, there were no MDR reportable adverse events filed with FDA for thecurrent model(s) or for any new model(s) that may have been added to the initial baselinereport during that designated time period and there were no other changes in the informationpreviously submitted. This waiver remains in effect until the manufacturer files an adverseevent report either for the current model(s), or the manufacturer adds new models after the last

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update. In this case, an annual update report is required at the time of the next annualregistration and will contain the same information identified above. The update must includethe designated information covering the time frame from the last baseline report update to thepresent. This may be a period longer than 12 months.

Interim baseline update. Manufacturers who submit baseline reports based on a devicefamily may add a new model(s) to a device family. A baseline update report is required for theadditions(s). However, if, prior to submission of the annual update, a new model(s)subsequently becomes the subject of an MDR reportable adverse event, then an interim updatereport is required, to report the new model involved in the event. (See the “Instructions forCompleting Form 3417” in Appendix A.)

4) Supplemental report [§803.56]

Manufacturers must submit a supplemental report, using Form 3500A, if they obtainadditional information denoted as unknown (UNK) or not available (no information at thetime, NI) on the original 30-day or 5-day MDR reports. Additionally, a supplemental reportis required when new facts prompt the manufacturer to alter any information submitted in theoriginal MDR report. The supplemental information must be submitted on Form 3500A withinone month (30 calendar days) following receipt of the information.

The number of follow-ups necessary to obtain MDR information depends upon the natureand severity of the event reported. It is FDA’s position that MDR follow-up investigationsshould focus on obtaining information and not on the number of attempts. FDA cannotprovide an absolute number of attempts to follow-up since the intensity, nature and duration ofan MDR follow-up depend upon the firm’s assessment of the risk. Therefore, “adequate”follow-up cannot be characterized by the selection of a pre-determined/averaged number ofattempts. Each MDR event can be unique and a standard number of follow-up attempts wouldnot be in the best interest of the public health.

FDA requires that a “good faith effort” be made to obtain information. At least onerequest for information should be made in writing. Firms must document follow-up attemptsand document reasons why MDR information cannot be obtained. A firm’s files shouldinclude a record of each attempt to obtain information, and the nature of the response by thereporter. All of this information will be reviewed by FDA to determine if a firm has made areasonable attempt to follow-up and obtain the required information.

If the initial report contained all the required information, and new information does notchange the facts and/or conclusion reported in the original MDR report, a supplemental reportis not required. However, the manufacturer should maintain any new information in themanufacturer’s MDR files.

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5) Annual certification [§803.57]

Section 510(d) of the Federal Food, Drug, and Cosmetic Act (the act) [21 U.S.C.360I(d)] provides that each manufacturer, importer, and distributor shall certify that they did file acertain number of medical device reports (MDR’s) in the previous twelve months or they did notfile any MDR’s. In the Federal Register of December 11, 1995 (60 FR 63578), FDA published afinal rule implementing this statutory provision by requiring manufacturers to certify that they filedreports for all reportable events required under the rule for the previous twelve months and anumerical summary of MDR’s that they submitted, or to certify that they did not receive anyreportable events during the reporting period [§803.57 (21 CFR 803.57)]. The final rule requiredcertification to be made by the company’s president, chief executive officer (CEO), or otherofficial most directly responsible for the firm’s operations. This provision was stayed on July 23,1996.

In the Federal Register of March 20, 1997 (62 FR 13302), FDA published a final ruleamending its medical device manufacturer and distributor certification regulation to allowmanufacturers to designate more than one certifying official, each of whom would sign acertification statement for his or her identified organizational component or site; and to amend thecertification statement to minimize concerns relating to liability from unintentional reportingerrors, and indicate that the certifying official is making the certification statements, to the best ofhis/her knowledge and belief. This action was taken to help FDA carry out its public healthprotection responsibilities relating to medical devices. This action provides reporting entities withgreater flexibility in the certification process while reducing the regulatory burden. Thisamendment is effective on May 19, 1997, at which time the existing stay will end.

FDA REQUESTS FOR ADDITIONAL INFORMATION [§803.15]

FDA may determine that protection of the public health requires additional or clarifyinginformation. In these instances, the agency will notify the reporting entity in writing, or by verbalrequest, of the additional information required. Any request will state the reason for requestingthe information, specify the date by which the information is to be submitted and clearly relate therequest to a reported event. All verbal requests will be confirmed in writing by the agency.

REPORTING FOR FOREIGN MANUFACTURERS [§803.58 and §807]

As mentioned earlier, on July 23, 1996 FDA published a Federal Register notice staying theU.S. Designated Agent (USDA) provision for foreign manufacturers. In addition, FDA statedthat it intends to propose that the requirements for the USDA to annually certify and submitpremarket notifications [510(k)] for the foreign manufacturer be deleted. The agency hasreceived comments regarding who may best perform the duties of the USDA.

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Foreign manufacturers are still subject to the remaining requirements in the MDRregulation and should submit MDR reports directly to FDA.

Due to the stay of the USDA provisions, the 1996 edition of Title 21 of the Code of FederalRegulations (CFR), Parts 800-1299, is incorrect. In particular, section 807.40 is incorrect. Thestay has delayed the implementation of the new version of section 807.40. The correct version ofsection 807.40 is found in the 1995 edition of 21 CFR. The 1995 version is printed below.

§807.40 Establishment registration and device listing for foreign manufacturers ofdevices.

(a) Foreign device establishments, that export devices into the U.S., are requested to registerfollowing the procedures of subpart B of this part, unless exempt under subpart D of this part.

(b) Foreign device establishments that export devices into the U.S., whether or not theestablishment is registered, shall comply with the device listing requirements unless exemptfrom registration as stated in §807.65. Those foreign owners or operators, for which thereexists joint ownership and control with a domestic establishment, may have the domesticestablishment submit listing information and maintain the historical file. A foreign owner oroperator may authorize a domestic initial distributor to submit listing information when jointownership and control do not exist, only if:

(1) The domestic distributor is the sole initial distributor of a device manufactured by theforeign owner or operator; and

(2) The foreign owner or operator submits a letter to FDA authorizing the initial distributor tolist on their behalf and maintain the historical files.

(c) Except for a device imported or offered for import that has in effect an approvedexemption for investigational use under section 520(g) of the act, a device may not beimported from a foreign device establishment into the U.S. unless it is listed at the intervalspecified for updating device listing information in §807.30(b). The device listing informationshall be in the English language.

(d) Foreign device establishments shall submit, as part of the device listing, the name andaddress of the establishment and the name of the individual responsible for submitting devicelisting information. Any changes in this information shall be reported to FDA at the intervalsspecified for updating device listing information in §807.30(b).

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REPORTING FOR USER FACILITIES AND DISTRIBUTORS

User facilities are required to report device-related deaths using MedWatch Form 3500A tothe FDA and the manufacturer within 10 working days. They must submit reports of seriousinjuries only to the manufacturer. However, if the manufacturer is unknown, reports of seriousinjuries must be submitted to FDA. The user facility is not required, but is encouraged, to reportreportable malfunctions to the manufacturer.

Distributors are required to submit deaths and serious injuries to both FDA and themanufacturer within 10 working days. Distributors must also submit reportable malfunctions tothe manufacturer, not the FDA, within 10 working days. Distributors are requested, not required, to use MedWatch Form 3500A for purposes of reporting. In cases where themanufacturer receives information regarding a reportable event, other than by means of a form3500A, they are required to complete all applicable sections of the form.

WHERE TO SUBMIT REPORTS [§803.12]

All MDR reports should be sent to:

Food and Drug AdministrationCenter for Devices and Radiological HealthMedical Device ReportingPO Box 3002Rockville, MD 20847-3002

FDA will accept more than one type of report per envelope. If multiple types of reports areenclosed, the envelope should be labeled indicating each type of report enclosed. In addition, anyMDR report may be faxed to FDA following approval. A request for approval of facsimilereports can be obtained by calling 301-827-7537.

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To ensure the proper processing of all reports, the outside of the envelope shall be labeled in aspecific manner. The mailing and labeling requirements are noted in the following table:

TYPE OFMDR REPORT

IDENTIFICATION OF ENVELOPE(PLACE IN LOWER LEFT-HAND CORNER OFTHE ENVELOPE ABOVE BAR CODE LEVEL)

5-Day (Form 3500A) 5-day Report

30-Day (Form 3500A) 30-day Manufacturer Report

Supplemental (Form 3500A) Manufacturer Supplemental Report

Baseline (Form 3417) Baseline Report or Annual/InterimUpdate-Baseline Report

Annual Certification (Form 3381) Manufacturer Annual Certification Report

WHERE TO REPORT A PUBLIC HEALTH EMERGENCY

If a manufacturer believes that there is a public health emergency, they should contact:

FDA Emergency Operations BranchOffice of Regional Operations, HFC-162Phone: 301-443-1240FAX: 301-443-3757

The telephone report should be followed by a facsimile report.

ENGLISH REPORTING REQUIREMENTS [§803.13]

All written or electronic MDR reports, including requested additional information, must be inEnglish.

ELECTRONIC REPORTING [§803.14]

Manufacturers may send MDR reports electronically once they have received written approvalfrom FDA. This includes the use of electronic media such as magnetic tape, disc and computer-to-computer communication. FDA encourages manufacturers to computerize the required reportforms. However, a request for an electronic facsimile (reproduction) approval of any form mustbe made in writing to FDA. The request must include a copy of the proposed form and a sampleof a completed form. It is not necessary for a facsimile form to be generated as a two-sided

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document. Manufacturers can use programs that automatically create continuation pages whenthe text exceeds the space allowed for a particular block on a form. FDA is not acceptingfacsimiles that increase the size of the item block or cause the original form to be significantlymodified. The request for facsimile approval should be addressed to the MEDWATCH addressdesignated below. A copy of all the requests for Form 3500 or Form 3500A approval should beforwarded to the Director, Division of Surveillance Systems at the address designated below.

For MedWatch Form 3500A (Mandatory) or Form 3500 (Voluntary), contact:

MEDWATCH: The FDA Medical Products Reporting ProgramOffice of the Commissioner, HF-2Food and Drug Administration5600 Fishers LaneRockville, Maryland 20857

For Form 3417 (Baseline) or Form 3381 (Annual Certification) contact:

ATTN.: Computer Generated Form Approval RequestDirector, Division of Surveillance SystemsOffice of Surveillance and Biometrics, HFZ-530Center for Devices and Radiological Health1350 Piccard DriveRockville, Maryland 20850

EXEMPTIONS, VARIANCES, AND ALTERNATIVE REPORTING REQUIREMENTS[§803.19]

The new MDR regulation includes provisions for waivers from all or some provisions. Theregulation explicitly exempts the following three types of persons:

• licensed practitioners who prescribe or administer devices intended for use in humans, andwho manufacture or import devices solely for use in diagnosing and treating persons withwhom the practitioner has a "physician-patient" relationship;

• a person who manufacturers devices intended for use in humans solely for such person'suse in research or teaching and not for sale, including any person who is subject toalternative reporting requirements under the Investigational Device Exemption (IDE)regulation (21 CFR Parts 812 and 813) because they are conducting a clinical researchstudy. However, the IDE regulation requires the reporting of unanticipated adversedevice effects (21 CFR 812.46); and

• dental or optical laboratories.

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In addition, manufacturers can submit requests for exemption from all or part of therequirements of the MDR regulation. This includes variances and alternative reportingrequirements. FDA must approve a manufacturer’s request in writing before an exemption,variance or alternative reporting can be carried out. An exemption, variance or alternative reportapproved may also be granted at the discretion of FDA in the absence of a request. FDA canrevoke any approval in writing if they decide that the protection of the public health justifies areturn to the standard MDR reporting requirements.

A variance may include a modification of the data elements required on the mandatoryreporting forms. An alternative report allows a modification in the timing of report submissionsand is a type of variance. For example, a firm may request, instead of reporting each event within30 days after becoming aware, that the reports be submitted every two months, quarterly,semiannually or annually.

When an exemption, variance or alternative report is granted, FDA may impose otherreporting requirements to protect public health. Manufacturers must provide any reports orinformation required by FDA in approving any reporting modifications. The conditions ofapproval replace or supersede the reporting requirements of the MDR regulation.

Each request for an exemption or variance should include an explanation of the impact of thedevice problem on the patient and why the requested reporting approval is more appropriate thanthe standard MDR reporting requirements. Each request should include the followinginformation:

1. Firm identification, including manufacturing site(s) of the device(s),2. Complete product identification and description,3. Type of approval requested (i.e., an exemption, a variance, an alternative reporting

approval),4. Type of report(s) involved (e.g., serious injuries, malfunctions),5. Particular type of event(s) involved,6. Rationale for the request,7. Number of reports submitted to date and approximate number reported annually, and8. Discussion of previous complaint history.

Submit an original and one copy of the request, and label the lower left-hand corner of theenvelope with the type of request being made, for example, “Alternative Reporting Request.”

Manufacturers should submit requests to:

Director, Division of Surveillance SystemsOffice of Surveillance and Biometrics, HFZ-530Center for Devices and Radiological Health1350 Piccard DriveRockville, Maryland 20850

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As of July 31, 1996, the new regulation superseded all previously granted exemptions,variances, and alternative reporting requests from the 1984 MDR regulation.

MDR Exemptions. Since July 30, 1996, FDA has reissued the following four exemptions:

• Remedial Action Exemption - E1996001 - published on July 30, 1996• Breast Implant Exemption - E1996002 - published on August 7, 1996• Needlesticks and Blood Exposure Exemption - E1996003 - published on August 9, 1996• Intraocular Lens Exemption - E1996004 published on August 7, 1996

Copies of these exemptions are available through the CDRH Home Page. (Refer to AppendixA.)

Manufacturer Report Number Variances. FDA is aware that some firms are havingproblems implementing the Manufacturer Report Number (MRN) format required by theregulation. In response to these problems, FDA has issued variances from the reportingrequirements. These variances provide the means for the majority of firms to easily generate theMRN. Copies of these variances are available through the CDRH Home Page. (Refer toAppendix A.)

In addition, requested alternative report approvals have been reissued.

HOW TO REPORT [§803.20]

There are two versions of the MedWatch form. The voluntary MedWatch Form 3500 is foruse by consumers and health care professionals for the submission of voluntary reports involvingmedical devices. These voluntary reports for medical devices are forwarded from the FDAMedWatch Office to the Center for Devices and Radiological Health for review, evaluation anddissemination to the manufacturer.

The mandatory MedWatch Form 3500A is to be used by both user facilities and medicaldevice manufacturers for the reporting of device-related deaths, serious injuries and reportablemalfunctions required under the December 11, 1995 MDR regulation. Form 3500A has blocksthat must be completed by all reporters, and other blocks designed to be completed by either theuser facility or the manufacturer. (Refer to Appendix A on how to obtain copies of Form 3500A,and the Coding Manual with full instructions, or the abbreviated instructions for completingMedWatch Form 3500A.)

• Blocks A through E (Excluding Block C) are to be filled out by user facilities ordistributors. Blocks A through E include information regarding the patient, the event, thedevice and the initial reporter. The initial reporter is the person that first contacted theentity required to report regarding the reportable event.

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• Block F is to be filled out by the user facilities and distributors. Block F includesinformation regarding their name, address and the event problem codes. The user facilitymust enter codes which most accurately describe the event. Codes used for this purposecan be found in the MedWatch Coding Manual. (Refer to Appendix A.)

• Blocks G and H are to be filled out by the manufacturer. These blocks includeinformation regarding the manufacturer’s name and address, evaluation codes and, ifapplicable, the type of remedial action taken. The evaluation codes will include themethods, results and conclusion drawn by the manufacturer for the event. These codesalso can be found in the MedWatch Coding Manual. (Refer to Appendix A.)

Manufacturers are not required to recopy information submitted to them on MedWatch Form3500A, unless they are copying the information onto an electronic medium. The manufacturershould always include, without alteration, a copy of the MedWatch form(s) received from theuser facility and distributor, with their own submission. It is important to note that themanufacturer has the responsibility to provide any missing information on the Form 3500A,including any missing event codes or patient information from Blocks A through F. If there is anymissing information in these blocks, manufacturers are required to provide the information.

If the manufacturer corrects or supplies information missing in Blocks A, B, D, E or F theyshould do so on a separate Form FDA 3500A, not the form received from the user facility ordistributor. This is the only way that FDA will know which entity is responsible for reporting theinformation. Do not make corrections on the original Form 3500A received from the userfacility or distributor. The manufacturer may place added or corrected information inBlock H.11 of the manufacturer’s Form 3500A. When correcting or supplying missinginformation from other reporters (User or distributor), the manufacturer should attach a copy ofthe initial reporter's form 3500A to the manufacturer’s report form.

Manufacturers do not have to report events when there is information available that wouldcause a person qualified to make a medical judgement (for example, physician, nurse, riskmanager, or biomedical engineer) to conclude that their device did not cause or contribute to areportable event. The information used to decide that the event was not reportable must bedocumented in the MDR files.

REPORTING CODES (CODING MANUAL) [§803.21]

FDA has developed instructions and a coding manual for completing MedWatch Form 3500Aentitled “Instructions for Completing Form 3500A with Coding Manual for Form 3500A” (Referto Appendix A to obtain copies.)

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3 WRITTEN PROCEDURES, RECORD KEEPING AND PUBLIC DISCLOSURE

WRITTEN PROCEDURES [§803.17]

Manufacturers are required to establish and maintain written procedures for implementation ofthe MDR regulation. These procedures should include internal systems that:

• provide for timely and effective identification, communication and evaluation ofadverse events;

• provide a standardized review process and procedures for determining whether or notan event is reportable; and

• provide procedures to insure the timely transmission of complete reports.

These procedures should also include documentation and record keeping requirements for:

• information that was evaluated to determine if an event was reportable;

• all medical device reports and information submitted to FDA;

• any information that was evaluated during preparation of annual certificationreport(s); and

• systems that ensure access to information that facilitates timely follow up andinspection by FDA.

Each manufacturer has certain discretion to decide the detail and depth of information thattheir written MDR procedures contain. FDA suggests that manufacturers provide policy andprocedure information regarding “typical” adverse events or product problems that may be MDRreportable. FDA also suggests that the procedures describe the investigation protocol that theywill follow, e.g., how many attempts will be made to contact the reporter either by phone, FAXor letter before the investigation is closed; that the complaint records will contain a concise butthorough description of the adverse event or product problem, that the complaint records will belegible, etc. The number of follow-ups necessary to obtain MDR information depends upon thenature and severity of the event reported. It is FDA’s position that MDR follow-up investigationsshould focus on obtaining information and not on the number of attempts. FDA cannot providean absolute number of attempts to follow-up since the intensity, nature and duration of an MDRfollow-up depend upon the firm’s assessment of the risk. Therefore, “adequate” follow-up cannot

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be characterized by the selection of a pre-determined/averaged number of attempts. Each MDRevent can be unique and a standard number of follow-up attempts would not be in the best interestof the public health.

FDA requires a “good faith effort” be made to obtain information. At least one request forinformation should be made in writing. Firms must document follow-up attempts and documentreasons why MDR information cannot be obtained. A firm’s files should include a record of eachattempt to obtain information, and the nature of the response by the reporter. All of thisinformation will be reviewed by FDA to determine if a firm has made a reasonable attempt tofollow up and obtain the required information.

MDR EVENT FILES [§803.18(b)(1)]

Manufacturers must maintain complete MDR files in either written or electronic form. Theymust identify them prominently as "MDR Files" so they can be found easily. Manufacturers’MDR files may be maintained as part of their complaint file required under the Quality System(QS) regulation (§820.198). An MDR report submitted to FDA is not considered in compliancewith the MDR regulation unless the manufacturer evaluated the event in accordance with the QSregulation, regarding investigation of a possible device failure [See sections 820.198(c), (d) and(e)]. There must be a record of this investigation documented in the complaint file. Manufacturers are to maintain records related to an event (whether reportable or not) for twoyears from the date of the event or a period equivalent to the expected life of the device,whichever is longer. MDR files may incorporate references to other information sources such asmedical records, patient files, and engineering reports.

MDR files must contain:

• information related to the event, including all documentation of deliberations and decision-making processes used to decide whether the event was or was not reportable; and

• the original or a copy of the initial record complaint/event. This record should include theavailable information needed to complete the Form 3500A. The record may be adocumented telephone call, a letter or facsimile, a service report, documents related to alawsuit, a voluntary Form 3500 received from a health care professional or consumer, or amandatory Form 3500A received from a user facility and/or a distributor,

• copies of any records documenting the firm’s attempts to follow-up and obtain missing oradditional information about the event. When the manufacturer cannot obtain information,they must write an explanation of these events for inclusion in the file. In addition, theremust be an explanation of why any missing information, required by the MDR regulation,was not obtained and submitted.

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• copies of any test reports, laboratory reports, service records and reports, and records ofinvestigations.

• copies of all documentation involving the final assessment of the event, any deliberationand/or decision making processes used to determine whether an MDR report was or wasnot needed. When applicable, the final assessment should indicate what action (if any) thefirm took to assure that the cause of the event is corrected or otherwise mitigated.

• copies of all 3500As submitted to FDA, when applicable. This includes a copy of any3500As received from user facilities and distributors.

• documents verifying that the event has been evaluated in accordance with the applicablerequirements of 21 CFR 820.198.

• references to any other relevant documents or information used during assessment.

Manufacturers must permit any authorized FDA employee to access, copy, and verify therecords in the MDR files.

PUBLIC AVAILABILITY OF REPORTS [§803.9]

Any report in FDA’s control, including an FDA record of a telephone report, is subject topublic disclosure in response to a Freedom of Information (FOI) request. However, before publicdisclosure, FDA will delete from the report:

• any information that constitutes trade secret, commercial confidential or financialinformation;

• any personal, medical, and similar information (including the serial number of implanteddevices) which would constitute an unwarranted invasion of personal privacy; and

• any names and other identifying information of a third party voluntarily submitting anMDR report. This includes physicians, health care professionals, or other hospitalemployees unless they are the designated MDR contact person.

FDA will disclose, to a patient requesting a report, all information in the report concerningthem, except for trade secret and confidential commercial information.

FDA has promulgated a regulation [21 CFR §20.63(2)] that extends protection againstdisclosure of voluntary reports held by medical device, pharmaceutical, and biologicsmanufacturers by preempting state discovery laws.

When a manufacturer submits an MDR report and it contains information from a user facility,the facility name, address and MDR contact for the facility will be released to the public when

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requested. FDA will not, however, release the identity of the patient or any information that canbe used to identify the patient, such as the serial number of an implanted device. Nor will itrelease the name of any person other than the MDR contact.

DISCLAIMERS [§803.16]

The submission of a report or related information to the FDA and its release by FDA, doesnot necessarily reflect a conclusion by the party submitting the report or the FDA that the reportor information is an admission that the manufacturer, their employees, or the device caused orcontributed to the reportable event. FDA has included such a disclaimer on the MedWatch Form3500A at the bottom of the front page. Besides the FDA disclaimer, manufacturers may alsoinclude their own disclaimers in MDR reports.

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4 ENFORCEMENT

FDA may take the following actions to enforce the MDR regulation.

FDA-INITIATED OR VOLUNTARY RECALLS

Recalls are regulatory actions that enable FDA to remove a hazardous, potentially hazardous,or a misbranded product from the marketplace. Recalls are also used to convey additionalinformation to the user concerning the safe use of the product. Either FDA or the manufacturercan initiate recalls.

CIVIL MONEY PENALTIES

Section 303(f) of the Safe Medical Devices Act of 1990 authorized FDA, after an appropriatehearing, to impose civil money penalties for violations of the FD&C Act that relate to medicaldevices. In determining the amount of a civil penalty, FDA will take into account the nature,circumstances, extent, and gravity of the violations, the violator’s ability to pay, the effect on theviolator’s ability to continue to do business, and any history of prior violations. The civil moneypenalty may not exceed $15,000 for each violation and may not exceed $1,000,000 for allviolations adjudicated in a single proceeding, per person.

WARNING LETTERS

FDA issues written communications to a firm, indicating that the firm may incur more severesanctions if the violations described in the letter are not corrected. Warning letters are issued tocause prompt correction of violations that pose a hazard to health or that involve economicdeception. FDA generally issues the letters before pursuing more severe sanctions.

SEIZURE

A seizure is a civil court action against a specific quantity of goods which enables FDA toremove these goods from commercial channels. After seizure, no one may tamper with the goodsexcept by permission of the court. The court usually gives the owner or claimant of the seizedmerchandise approximately 30 days to decide a course of action. If they take no action, the courtwill recommend disposal of the goods. If the owner decides to contest the government’s charges,the court will schedule the case for trial. A third option allows the owner of the goods to requestpermission of the court to bring the goods into compliance with the law. The owner of the goodsis required to provide a bond (security deposit) to assure that they will perform the orders of thecourt, and the owner must pay for FDA supervision of any activities by the company to bring thegoods into compliance.

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CITATION

A citation is a formal warning to a firm of intent to prosecute the firm if violations of theFD&C Act are not corrected. It provides the firm an opportunity to convince FDA not toprosecute.

INJUNCTION

An injunction is a civil action filed by FDA against an individual or company. Usually, FDAfiles an injunction to stop a company from continuing to manufacture, package or distributeproducts that are in violation of the law.

PROSECUTION

Prosecution is a criminal action filed by FDA against a company or individual chargingviolation of the law for past practices.

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5 TERMS AND DEFINITIONS

BECOMES AWARE [§803.3(c)]

Manufacturers are considered to have “become aware” of an MDR reportable event when:

• any employee becomes aware of a reportable event required to be reported within 30 days,or required to be reported within 5 days pursuant to a written request from FDA; or

• any employee who is a person with management or supervisory responsibilities overpersons with regulatory, scientific, or technical responsibilities, or a person whose dutiesrelate to the collection and reporting of adverse events, becomes aware that a reportableevent, from any information, including any trend analysis, necessitates remedial action toprevent an unreasonable risk of substantial harm to public health.

FDA believes these time frames for reporting should be triggered when employees of thereporting entities become aware of events. FDA believes that manufacturers have a directresponsibility to inform all employees to forward immediately adverse event information to theappropriate person designated by the manufacturer as responsible for MDR reporting.

CAUSED OR CONTRIBUTED [§803.3(d)]

A device may have “caused or contributed” to a patient’s death or serious injury, if the deathor serious injury was or may have been attributed to the device, or the device may have been afactor in the death or serious injury because of:

• device failure;• device malfunction;• improper or inadequate device design;• manufacture;• labeling; or• user error.

COMPLAINT

Section 820.3(b) of the Quality Systems regulation defines a complaint as, “any written,electronic or oral communication that alleges deficiencies related to the identity, quality,durability, reliability, safety, effectiveness, or performance of a device after it is released fordistribution.” All medical device manufacturers are subject to the complaint requirements in 21CFR Part 820, Quality System regulation and to the reporting requirements in 21 CFR Part 803, Medical Device Reporting (MDR) regulation. A complaint is any indication of the failure of adevice to meet customer or user expectations for quality or to meet performance specifications. A

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complaint may be lodged against any finished device released for distribution. Any complaintinvolving the possible failure of a device, labeling, or packaging to meet any of its specifications issubject to the provisions of 21 CFR 820.198, Complaint Files.

DEVICE FAMILY [§803.3(e)]

A “device family” is a group of one or more devices manufactured by or for the samemanufacturer and having the same basic design and performance characteristics related to devicesafety and effectiveness; intended use and function; and device classification and product code.

Devices that differ only in minor ways not related to safety or effectiveness can be consideredin the same device family. Factors such as brand name and common name of the device andwhether the devices were introduced into commercial distribution under the same 510(k) orpremarket approval application (PMA), may be considered in grouping products into devicefamilies.

DISCLAIMERS [§803.16]

The MDR regulation and Form FDA 3500A, contain a disclaimer statement. FDA providesthe disclaimer so that reporters are aware that the MDR information submitted to FDA does notnecessarily reflect a conclusion by the reporter, or the FDA, that the report or informationconstitutes an admission that the device, or the reporting entity or its employees, caused orcontributed to the reportable event. In fact, the regulation states that the reporter may deny thatthe report or information submitted constitutes any type of admission.

The FDA 3500A disclaimer states: “Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufacturer or product caused or contributed tothe event.”

The disclaimer in §803.16 states: “A report or other information submitted by a reportingentity under this part, and any release by FDA of that report or information, does not necessarilyreflect a conclusion by the party submitting the report or by FDA that the report or informationconstitutes an admission that the device, or the reporting entity or its employees, caused orcontributed to the reportable event. The reporting entity need not admit and may deny that thereport or information submitted under this part constitutes an admission that the device, the partysubmitting the report, or employees thereof, caused or contributed to a reportable event.”

A manufacturer may submit its own disclaimer. At the time the manufacturer submits the firstdisclaimer, it is entered into a computer database. Once the disclaimer is entered, it will not bemodified unless the manufacturer updates the disclaimer and notifies the Office of Surveillanceand Biometrics (OSB) (Refer to Appendix B) in writing. FDA recommends that firms label theoutside of the envelope containing such a change with the words, “DISCLAIMER UPDATE.” Whenever FDA releases a computer-generated copy of the MDR report under the Freedom ofInformation Act, they will duplicate the manufacturer’s latest disclaimer on the copy.

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DISTRIBUTOR [§804.3(d)]

A “distributor” is any person, including an importer, who furthers the marketing of a devicefrom the place of original manufacture to the person who makes final delivery or sale to theultimate user, but who does not repackage or otherwise change the device or the container,wrapper, or labeling of the device or device package.

EXPECTED LIFE [§803.3(i)]

“Expected life” is the time that a device is expected to remain functional after it is placed intouse.

INFORMATION REASONABLY KNOWN

The type of information that is "reasonably known" to the manufacturer is listed in§803.50(b)(i)-(iii). It includes information that can be obtained by contacting a user facility,distributor and/or initial reporter, any information in the manufacturer's possession, or anyinformation that can be obtained by analysis, testing or other evaluation of the device. In applyingthis requirement, FDA will not ask the manufacturer for information that was not obtainable.

MALFUNCTION [§803.3(m)]

A “malfunction” is a failure of the device to meet its performance specifications or otherwiseperform as intended. Performance specifications include all claims made in the labeling for thedevice. A malfunction should be considered reportable if any one of the following is true:

• the chance of a death or serious injury resulting from a recurrence of the malfunction isnot remote;

• the consequences of the malfunction affect the device in a catastrophic manner that maylead to a death or serious injury;

• the malfunction causes the device to fail to perform its essential function and compromisesthe device’s therapeutic, monitoring or diagnostic effectiveness which could cause orcontribute to a death or serious injury, or other significant adverse device experiences. Theessential function of a device refers not only to the device’s labeled use, but for any usewidely prescribed within the practice of medicine;

• the malfunction involves a long-term device implant that would prevent the implant fromperforming its function;

• the device is considered life-supporting or life-sustaining, and thus essential to maintaininghuman life; or

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• the manufacturer takes or would be required to take action under section 518 or 519(f) ofthe FD&C Act as a result of the malfunction of the device or other similar devices.

Reporters do not need to assess the likelihood that a malfunction will recur. The regulationassumes that if a malfunction has occurred once, the malfunction will recur.

Malfunctions are not reportable if they are not likely to result in death, serious injury or othersignificant adverse event experience.

A malfunction which is or can be corrected during routine service or device maintenance mustbe reported if the recurrence of the malfunction is likely to cause or contribute to a death orserious injury if it were to recur.

MANUFACTURER [§803.3(n)]

A “manufacturer” is any person who manufactures, prepares, propagates, compounds,assembles, or processes a device by chemical, physical, biological or other procedures. The termincludes any person who:

• repackages or otherwise changes the container, wrapper or labeling of a device infurtherance of the distribution of the device from the original place of manufacture;

• initiates specifications for devices manufactured by a second party for subsequentdistribution by the person initiating the specifications;

• manufactures components or accessories which are devices that are ready to be used andare intended to be commercially distributed and intended to be used as is, or are processedby a licensed practitioner or other qualified person to meet the needs of a particularpatient; or

•

MANUFACTURER REPORT NUMBER (MEDWATCH FORM 3500A) [§803.3(o)]

The “Manufacturer Report Number” is the number that identifies each individual adverseevent report submitted by a manufacturer. It consists of three parts:

• registration number of the manufacturing site,• the four digit calendar year the report was submitted, and• the five digit sequence number of the report submitted during the year.

is the US Designated Agent of a foreign manufacturer. STAYED 7/23/96

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The manufacturer report number entered in the top right-hand corner of the Form FDA3500A, and in Block G.9 replaces the FDA assigned MDR report accession number (1984regulations). Manufacturers no longer have to wait for FDA to assign an MDR report numbersince the manufacturer report number is self-generated.

MEDICAL PERSONNEL [§803.3(r)]

“Medical personnel” refers to individuals who:

• are licensed, registered, or certified by a State, territory, or other governing body, toadminister health care;

• have received a diploma or a degree in a professional or scientific discipline;• are employees responsible for receiving medical complaints or adverse event reports; or• are supervisors of such persons.

MDR REPORTABLE EVENTS [§803.3(q)]

Manufacturers must report all “MDR reportable events” to FDA on Form FDA 3500A. Areport is required when a manufacturer becomes aware of information that reasonably suggeststhat one of their marketed devices has or may have caused or contributed to a death, seriousinjury, or has malfunctioned, and that the device or a similar device marketed by the manufacturerwould be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

PERMANENT IMPAIRMENT [§803.3(aa)(2)]

“Permanent” impairment means irreversible impairment or damage to a body structure orfunction, excluding trivial impairment or damage.

PERSON QUALIFIED TO MAKE A MEDICAL JUDGEMENT [§803.53(c)(2)]

FDA expects a “person qualified to make a medical judgement” to be a health careprofessional, e.g., a doctor, a nurse, a biomedical engineer or a risk manager. This person doesnot have to be an employee of the firm but may be an outside consultant.

REASONABLY SUGGESTS [§803.20(c)]

“Reasonably suggests” includes any information, such as professional, scientific, or medicalfacts and observations or opinions, that would reasonably suggest that a device has caused orcontributed to a reportable event.

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REMEDIAL ACTION [§803.3(y)]

“Remedial action” is any action, other than routine maintenance or servicing of a device,necessary to prevent recurrence of a reportable event.

SERIOUS INJURY/SERIOUS ILLNESS [§803.3(aa)(1)]

“Serious injury/(serious illness)” is an injury or illness that:

• is life threatening, even if temporary in nature;

• results in permanent impairment of a body function or permanent damage to a bodystructure; or

• necessitates medical or surgical intervention to preclude permanent impairment of a bodyfunction or permanent damage to a body structure.

SHELF LIFE [§803.3(bb)]

“Shelf life” is the maximum time a device will remain functional from the date of manufactureuntil it is used in patient care.

USER ERROR

The term “user error” means any error made by the person using the device. A user error maybe the sole cause or merely contribute to a reportable event. As with the 1984 regulation, there isthe requirement for reports of certain adverse device events caused by user error. For example,device injuries attributed to user error may show that the device is misbranded within the meaningof section 502(f) of the FD&C Act [21 U.S.C. 352(f)] in that the device fails to bear adequatedirections for use or adequate warnings. Reports of adverse events that result from user errormay alert FDA to the need for improved labeling to prevent future injuries. (Refer to the FRpreamble, page 63583, Final Rule, December 11, 1995.)

USER FACILITY [§803.3(f)]

A “user facility” is a hospital, ambulatory surgical facility, nursing home, or outpatientdiagnostic or outpatient treatment facility.

WORK DAY [§803.3(ee)]

“Work day” refers to any day Monday through Friday, excluding Federal holidays.

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APPENDIX A

SOURCES OF AVAILABLE MDR RELATED DOCUMENTS

SOURCES TO OBTAIN DOCUMENTS FREE OF CHARGE

1) CDRH Home Page (Home Page)

Many FDA MDR related forms and instructions, FDA exemptions and variances, and otherMDR-related documents are available through the CDRH Home Page via the World Wide Web(WWW). The CDRH Home Page address is http://www.fda.gov/cdrh.

The CDRH Home Page includes:

• MDR related documents issued by CDRH,• MDR related Federal Register notices,• Form related instructions,• MDR related exemptions and variances,• MDR guidance documents for user facilities, distributors and manufacturers, and• Product Code Classification data base.

MedWatch software is available. The software can be downloaded and used to complete aForm 3500 or 3500A on a personal computer. A hard copy may then be printed and mailed toFDA. This software is not for use for electronic submission of MDR reports. It just allows theuse of a personal computer instead of a typewriter.

To download the software go to: http://www.fda.gov./cdrh/mdwtchgn.htmlFollow the Instructions. If you have any difficulty call the MedWatch Office at 1-800-FDA-1088and press zero, or send a facsimile to 301-443-5776.

For additional information on the WWW site, please call the CDRH FOD (see 2 below) andrequest shelf number 1799. The WWW allows access to information including text, graphics, andfiles which may be downloaded to a personal computer. The CDRH Home Page is updatedfrequently to include any new MDR documents or notices issued by CDRH.

To access the MDR section of the CDRH Home Page via the WWW:(Type) http://www.fda.gov/cdrh/mdr.html

A list of all available MDR topic areas will be displayed. The list includes MDR forms andinstructions and Federal Register notices. Many documents are viewable with a pdf reader,which can be downloaded from the Home Page.

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The Internet List Server will be used to distribute MDR policies, guidance documents,announcements, and Home Page updates via the Internet beginning early 1997. Those with thecapability to receive Internet E-mail may wish to subscribe to this service by sending an E-mailmessage to:

fdalists@archie.fda.gov

The text of the message must read; “subscribe MDR-guide.” In response, you will receive ashort introduction to the MDR-guide subscription list.

2) CDRH Facts-On-Demand (FOD)

This automated fax system allows anyone to obtain CDRH information, 24 hours a day,seven days a week by calling 800.899.0381 or 301.827.0111 from a touch-tone telephone. Toreceive a document which will give you a list of all available sources of MDR information; at thefirst voice prompt press the number one to access DSMA Facts, at the second voice prompt presstwo, and then enter the document number [799] followed by the pound(#) sign. Then follow theremaining voice prompts to complete your request.

SOURCES AVAILABLE FOR THE PURCHASE OF MDR DOCUMENTS

1) National Technical Information Service (NTIS) Phone number: 703.487.4650Fax number: 703.321.8547For additional information on the NTIS system please, call the CDRH FOD (see 2 above) and

request shelf number 3799.

2) Health Care & Industry Organizations (HCIO) - For a list of organizations that haveagreed to help in the distribution of this information, please call the CDRH FOD (see 2 above)and request shelf number 4799.

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TABLES OF AVAILABLE MDR RELATED DOCUMENTS AND RESOURCES

MEDICAL DEVICE REPORTING FORMS

Form # Title Edition Sources

FDA-3500A Mandatory MedWatch 6/93 Home Page, FOD #854, NTIS, HCIO

FDA-3417 Baseline Report 3/96 Home Page, FOD #407, NTIS, HCIO

MEDICAL DEVICE REPORTING GUIDANCE DOCUMENTS

Title Edition Sources

Medical Device Reporting: An Overview 4/96 Home Page, FOD #509, NTIS

Medical Device Reporting for USER FACILITIES 4/96 Home Page, FOD #989, NTIS,

Medical Device Reporting for DISTRIBUTORS 4/96 Home Page, FOD #988, NTIS

Medical Device Reporting for MANUFACTURERS 3/97 Home Page, FOD #987, NTIS

Remedial Action Exemption - E1996001 7/96 Home Page, FOD #188,

Breast Implant Exemption - E1996002 8/96 Home Page, FOD #452,

Needlesticks and Blood Exposure Exemption - E1996003 8/96 Home Page, FOD #250,

Intraocular Lens (IOL) Exemption - E1996004 8/96 Home Page, FOD #216,

Variances(#1-#4) from Report Number Format 7/96 Home Page, FOD # 1059,

Variance (#5) from Report Number Format 8/96 Home Page, FOD #1060

MDR Policy List Server - Information on how tosubscribe to the List Server

8/96 FOD #1094

MDR - Interim Compliance Program 7382.830,Attachment E

7/96 FOD #1098

MEDICAL DEVICE REPORTING FEDERAL REGISTER NOTICES

Title Edition Sources

Final Rule: Medical Devices; Medical Device UserFacility and Manufacturer Reporting, Certification andRegistration (Docket 91N-0295). Initial Rule (published12/11/1995)

12/95 Home Page, FOD #336, NTIS

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MEDICAL DEVICE REPORTING FEDERAL REGISTER NOTICES

Title Edition Sources

Final Rule: Medical Devices; Medical Device Reporting;Baseline Reports; Stay of Effective Date.

7/96 Home Page, FOD #1096

Final Rule: Medical Devices; Medical Device Distributerand Manufacturer Reporting, Certification Registration,Listing, and Premarket Notification Submission; Stay ofEffective Date; Revocation of Final Rule.

7/96 Home Page, FOD #1074

Final Rule: Medical Device Reporting; AnnualCertification.

3/97 Home Page, FOD #1090

MEDICAL DEVICE REPORTING FORM INSTRUCTIONS

Title Edition Sources

Instruction for Completing Form 3500A withCoding Manual for Form 3500A

12/95 Home Page, FOD #853, NTIS, HCIO

Abbreviated Instructions for completing Form3500A

Home Page, FOD #973, NTIS, HCIO

Instructions for Completing Form 3417; BaselineReport

3/97 Home Page, FOD #1061

MEDICAL DEVICE REPORTING VIDEOTAPES

Title Edition Summary Source

MDR Teleconference (3 hours)

5/96 Discussions of intent and purpose of the MDRregulation, basic requirements, forms, follow-upand close out of reports.

NTIS

MDR Forms for DeviceManufacturers(30 minutes)

5/96 Detailed instructions for completing forms 3500A,Form 3417 and Form 3381.

NTIS

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APPENDIX B

SOURCES OF MANUFACTURER ASSISTANCE FOR COMPLYINGWITH THE MDR REGULATION

FDA realizes that manufacturers will need a variety of resources to help them understand andcomply with the MDR regulation. As a result, FDA has provided many documents to helpparties who are affected by the regulation. In addition, FDA has identified organizationalcomponents within the agency to provide answers to policy questions, filing questions, etc. Theywill likely develop additional documents as more experience with the new regulation is gained.

Information on how to obtain these documents is available through the CDRH Facts-On-Demand (FOD) system by calling either (800) 899-0381, or (301) 827-0111 and requesting shelfnumber 799.

FDA is considering various ways of making updates to this appendix periodically available. The most likely mechanism will be to use the CDRH Home Page. (Refer to Appendix A).

The MDR Telephone Number for General Assistance is: (301) 827-7537. FDA will retain thistelephone number, which was previously used by manufacturers to report serious injuries anddeaths. It will now be used by manufacturers, distributors and user facilities to arrange to faxtheir medical device reports to FDA. It may also be used to obtain assistance in filling out reportforms or for answers to MDR related questions. Manufacturers may also call the number to make5-day reports of events requiring remedial actions.

See Appendix A for information on accessing MDR-related documents.

General Questions regarding Medical Device Reporting

Division of Small Manufacturers Assistance (HFZ-220)Office of Health and Industry ProgramsCenter for Devices and Radiological Health1350 Piccard DriveRockville, Maryland 20850Telephone - (301) 443-6597, Toll free -(800) 638-2041FAX: (301) 443-8818

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To request that additional codes be added to the Coding Manual

MDR Coding Manual Coordinator, HFZ-533Office of Surveillance and BiometricsCenter for Devices and Radiological Health1350 Piccard DriveRockville, Maryland 20850

Assistance regarding MDR policy Interpretation, Exemptions, Variances and AlternativeReporting

ATTN.: QuestionsDivision of Surveillance Systems (HFZ-533)Office of Surveillance and BiometricsCenter for Devices and Radiological Health1350 Piccard DriveRockville, MD 20850Telephone - (301) 594-2735, Fax - (301) 827-0038

Assistance in completing forms

ATTN.: QuestionsInformation and Analysis Team (HFZ-531)Division of Surveillance Systems, Office of Surveillance and BiometricsCenter for Devices and Radiological Health1350 Piccard DriveRockville, MD 20850Telephone - (301) 594-2731, Fax - (301) 827-0038